Zirlux

Basic Information

• Brand Name: Zirlux
• Primary DI: 00304040111017
• Version / Model: 9012497
• Catalog Number: 9012497
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-18
• Public Version: 2
• Public Version Date: 2021-10-29
• Public Version Status: Update
• Public Device Record Key: 4ee2ba3f-2fac-44f2-9534-26f29844fc11

Device Description

Zirlux Acetal LTD G2 98x22MM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHP	CLASP, PREFORMED	Dental	872.3285	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040111017	GS1

Device Sizes

Type	Value	Unit	Text
Height	22	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 193 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: n/a